-
However, a team of FDA toxicology experts reviewed the lorcaserin NDA and interpreted the data related to the lorcaserin carcinogenicity studies.
FORBES: FDA Responds To Outraged Arena Investors
-
Arena is going to need to agree with the FDA on an independent pathologist to figure out a path forward on the rat carcinogenicity studies it has already done and possibly do more animal experiments.
FORBES: How Long Will It Take For Arena's Obesity Drug To Be Approved?
-
Moreover, the lorcaserin carcinogenicity studies were also thoroughly reviewed and discussed by the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee, and the results of this scientific assessment were included in the background documents provided to the committee and discussed in Agency presentations at the Advisory Committee meeting.
FORBES: FDA Responds To Outraged Arena Investors